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Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer.
Vergote, Ignace; González-Martín, Antonio; Fujiwara, Keiichi; Kalbacher, Elsa; Bagaméri, Andrea; Ghamande, Sharad; Lee, Jung-Yun; Banerjee, Susana; Maluf, Fernando Cotait; Lorusso, Domenica; Yonemori, Kan; Van Nieuwenhuysen, Els; Manso, Luis; Woelber, Linn; Westermann, Anneke; Covens, Allan; Hasegawa, Kosei; Kim, Byoung-Gie; Raimondo, Miriam; Bjurberg, Maria; Cruz, Felipe Melo; Angelergues, Antoine; Cibula, David; Barraclough, Lisa; Oaknin, Ana; Gennigens, Christine; Nicacio, Leo; Teng, Melinda Siew Leng; Whalley, Elizabeth; Soumaoro, Ibrahima; Slomovitz, Brian M.
Afiliação
  • Vergote I; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • González-Martín A; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Fujiwara K; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Kalbacher E; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Bagaméri A; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Ghamande S; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Lee JY; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Banerjee S; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Maluf FC; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Lorusso D; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Yonemori K; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Van Nieuwenhuysen E; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Manso L; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Woelber L; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Westermann A; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Covens A; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Hasegawa K; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Kim BG; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Raimondo M; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Bjurberg M; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Cruz FM; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Angelergues A; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Cibula D; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Barraclough L; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Oaknin A; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Gennigens C; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Nicacio L; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Teng MSL; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Whalley E; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Soumaoro I; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
  • Slomovitz BM; From Universitaire Ziekenhuizen Leuven, Katholieke Universiteit Leuven, and the Belgium and Luxembourg Gynaecological Oncology Group, Leuven (I.V., E.V.N.), and Centre Hospitalier Universitaire de Liège, Liege (C.G.) - all in Belgium; Cancer Center Clínica Universidad de Navarra (A.G.-M.), Hospital
N Engl J Med ; 391(1): 44-55, 2024 Jul 04.
Article em En | MEDLINE | ID: mdl-38959480
ABSTRACT

BACKGROUND:

Recurrent cervical cancer is a life-threatening disease, with limited treatment options available when disease progression occurs after first-line combination therapy.

METHODS:

We conducted a phase 3, multinational, open-label trial of tisotumab vedotin as second- or third-line therapy in patients with recurrent or metastatic cervical cancer. Patients were randomly assigned, in a 11 ratio, to receive tisotumab vedotin monotherapy (2.0 mg per kilogram of body weight every 3 weeks) or the investigator's choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). The primary end point was overall survival.

RESULTS:

A total of 502 patients underwent randomization (253 were assigned to the tisotumab vedotin group and 249 to the chemotherapy group); the groups were similar with respect to demographic and disease characteristics. The median overall survival was significantly longer in the tisotumab vedotin group than in the chemotherapy group (11.5 months [95% confidence interval {CI}, 9.8 to 14.9] vs. 9.5 months [95% CI, 7.9 to 10.7]), results that represented a 30% lower risk of death with tisotumab vedotin than with chemotherapy (hazard ratio, 0.70; 95% CI, 0.54 to 0.89; two-sided P = 0.004). The median progression-free survival was 4.2 months (95% CI, 4.0 to 4.4) with tisotumab vedotin and 2.9 months (95% CI, 2.6 to 3.1) with chemotherapy (hazard ratio, 0.67; 95% CI, 0.54 to 0.82; two-sided P<0.001). The confirmed objective response rate was 17.8% in the tisotumab vedotin group and 5.2% in the chemotherapy group (odds ratio, 4.0; 95% CI, 2.1 to 7.6; two-sided P<0.001). A total of 98.4% of patients in the tisotumab vedotin group and 99.2% in the chemotherapy group had at least one adverse event that occurred during the treatment period (defined as the period from day 1 of dose 1 until 30 days after the last dose); grade 3 or greater events occurred in 52.0% and 62.3%, respectively. A total of 14.8% of patients stopped tisotumab vedotin treatment because of toxic effects.

CONCLUSIONS:

In patients with recurrent cervical cancer, second- or third-line treatment with tisotumab vedotin resulted in significantly greater efficacy than chemotherapy. (Funded by Genmab and Seagen [acquired by Pfizer]; innovaTV 301 ClinicalTrials.gov number, NCT04697628.).
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Oligopeptídeos / Protocolos de Quimioterapia Combinada Antineoplásica / Neoplasias do Colo do Útero / Anticorpos Monoclonais Humanizados / Recidiva Local de Neoplasia Limite: Adult / Aged / Aged80 / Female / Humans / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article
Texto completo
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Oligopeptídeos / Protocolos de Quimioterapia Combinada Antineoplásica / Neoplasias do Colo do Útero / Anticorpos Monoclonais Humanizados / Recidiva Local de Neoplasia Limite: Adult / Aged / Aged80 / Female / Humans / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article